Phase 3Completed
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy
- Sponsor
- Travere Therapeutics, Inc. (Industry)
- Enrolment
- 406 enrolled
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- sparsentan; irbesartan; Dapagliflozin
- Ages
- adults, older adults
- Registry
- NCT03762850, CTIS2023-505495-30-00, EUCTR2017-004605-41
Full record on ClinicalTrials.gov
From the registry
To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).
Primary outcomes
- Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36
History
Last registry update
Study completion
Results first posted
Primary completion
Started
Registered